Celldex Reports Third Quarter 2012 Financial Results

NEEDHAM, Mass.--(BUSINESS WIRE)--
Celldex
Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results
for the third quarter ended September 30, 2012. Celldex reported a net
loss of $15.0 million, or $0.25 per share, for the third quarter of 2012
compared to a net loss of $11.8 million, or $0.27 per share, for the
third quarter of 2011. For the nine months ended September 30, 2012,
Celldex reported a net loss of $42.3 million, or $0.75 per share,
compared to a net loss of $32.1 million, or $0.85 per share, for the
nine months ended September 30, 2011.

Anthony Marucci, President and Chief Executive Officer of Celldex
Therapeutics commented, "In the third quarter, Celldex continued to
advance our two lead programs, rapidly opening clinical sites for the
Phase 3 ACT IV study and the Phase 2 ReACT study of rindopepimut in
glioblastoma and preparing for an end-of-Phase 2 meeting with the Food
and Drug Administration to discuss future development of CDX-011 in
breast cancer. We look forward to presenting updates from these programs
at the Society for Neuro-Oncology Annual Meeting in November and the San
Antonio Breast Cancer Symposium in December. Further, by year-end, we
anticipate completing accrual in the solid tumor arm of the Phase 1
study of CDX-1127. We will also initiate a Phase 2 pilot study of
CDX-1135 in dense deposit disease. These events, coupled with ongoing
activity in a number of other programs, will set the stage for a series
of future significant milestones in 2013 and beyond."

At September 30, 2012, Celldex reported cash, cash equivalents and
marketable securities of $77.6 million, which the Company believes will
be sufficient to meet estimated working capital requirements and fund
planned program development into 2014. The decrease of $1.1 million from
June 30, 2012 is due primarily to planned, increased operational
expenses during the quarter related to ongoing studies of rindopepimut
(CDX-110), including the pivotal ACT IV study in patients with newly
diagnosed EGFRvIII-positive glioblastoma and the Phase 2 ReACT study in
patients with recurrent EGFRvIII-positive glioblastoma. The cash
outflows for these expenses were offset by the issuance of 2.0 million
shares during the quarter through our Cantor ATM facility that raised
net proceeds to Celldex of $10.9 million.

Third Quarter and Recent Highlights

Celldex continued to advance the CDX-011 program, including requesting
and preparing for an end-of-Phase 2 meeting with the Food and Drug
Administration to discuss future clinical and regulatory development
for this program. In May of 2012, Celldex presented positive, topline
results from the Phase 2b EMERGE study of CDX-011 in patients with
advanced, refractory breast cancer. Preliminary results suggested that
CDX-011 induced impressive response rates compared to currently
available therapies in patient subsets with advanced, refractory
breast cancers with high GPNMB expression (expression in ≥25% of tumor
cells) and in patients with triple negative breast cancer. Mature data
from the EMERGE study will be presented at the San Antonio Breast
Cancer Symposium in December.

Celldex continued its major initiative to open clinical sites to
support enrollment in the Phase 3 ACT IV study and the Phase 2 ReACT
study of rindopepimut in glioblastoma. In total, there are now more
than 150 clinical sites around the world that have been selected to
participate in the ACT IV study and, to date, 105 of these sites are
actively screening patients. The ReACT study is also well positioned,
with 25 study sites selected to participate and 21 actively screening
to date.

Celldex presented positive results from its Phase 1 study of CDX-1401
in solid tumors at the Society for Immunotherapy of Cancer (SITC)
Annual Meeting on October 26, 2012. The study evaluated the safety,
immunogenicity and clinical activity of escalating doses of CDX-1401
plus resiquimod and/or Poly ICLC (HiltonolTM) in 45
patients with advanced malignancies that had progressed after any
available curative and/or salvage therapies. 60% of patients had
confirmed NY-ESO-1 expression in archived tumor sample. Thirteen
patients maintained stable disease for up to 13.4 months with a median
of 6.7 months. Treatment was well-tolerated and there were no dose
limiting toxicities. Humoral responses were elicited in both NY-ESO-1
positive and negative patients. NY-ESO-1-specific T cell responses
were absent or low at baseline, but increased post-vaccination in 53%
of evaluable patients, including both CD4 and/or CD8 T cell responses.
Robust immune responses were observed with CDX-1401 with resiquimod
and Poly ICLC alone and in combination. The study has identified a
well-tolerated and immunogenic regimen and we expect that a study
sponsored by the Cancer Immunotherapy Trials Network will be initiated
in 2013.

Celldex received a new Small Business Innovation Research (SBIR)
contract award totaling approximately $200,000 from the National
Cancer Institute to develop the combination of two immune modulators,
CDX-301 (Flt3L) and CDX-1127 (an antibody that activates CD27) for use
during radiotherapy.

Celldex recently completed patient accrual and treatment in the
CDX-301 healthy volunteer study and expects to present preliminary
results from this Phase 1 study at the American Society of Hematology
(ASH) Annual Meeting in December 2012.

Present more mature data from the EMERGE Phase 2b study at the San
Antonio Breast Cancer Symposium in December 2012.

Complete Phase 1 accrual of the solid tumor arm of the CDX-1127 study
in the fourth quarter of 2012.

Initiate a Phase 2 pilot study of CDX-1135 in dense deposit disease
(DDD), an orphan kidney disease in children and young adults, by
year-end 2012. DDD is caused by uncontrolled activation of the
alternative pathway of complement, which leads to progressive kidney
damage and failure. CDX-1135 has been shown to inhibit the complement
cascade at both the C3 and C5 levels and has shown clear biologic
activity in DDD animal models and in earlier human clinical trials.

Participate in four upcoming financial conferences, the Brean Capital
2012 Life Sciences Summit and the Lazard Capital Markets 9th Annual
Healthcare Conference in November and the 2012 dbAccess BioFEST
Conference and the Oppenheimer Annual Healthcare Conference in
December.

Financial Highlights

Third Quarter Results

The net loss of $15.0 million for the third quarter of 2012 represents
an increase of $3.2 million when compared to the net loss of $11.8
million for the same period in 2011, primarily due to increases in
research and development (R&D) expenses and general and administrative
(G&A) expenses, partially offset by decreases in amortization expense.

Revenues for the third quarter of 2012 increased when compared to
revenues in 2011, primarily because of Rotarix® related
product royalty revenues and contracts and grants revenue received
related to an APC-based HIV vaccine being funded through an SBIR grant
in collaboration with The Rockefeller University.

R&D expenses in the third quarter of 2012 and 2011 were $11.8 million
and $8.6 million, respectively, an increase of $3.2 million from 2011 to
2012. The increase in R&D expenses between 2012 and 2011 primarily
reflect higher costs related to our rindopepimut program, including the
ACT IV and ReACT clinical trials, and related consulting expenses in
2012.

G&A expenses in the third quarters of 2012 and 2011 were $2.8 million
and $2.3 million, respectively, an increase of $0.5 million from 2011 to
2012. G&A expense in 2012 included higher personnel-related, consulting,
and rindopepimut-related commercialization expenses compared to 2011.

Nine Month Results

The net loss of $42.3 million for the first nine months of 2012
represents an increased loss of $10.2 million when compared to the net
loss of $32.1 million for the same period in 2011. The increased loss
resulted from higher R&D expenses primarily for clinical trial costs and
higher G&A expenses, partially offset by lower amortization expenses in
2012.

Revenues for the first nine months of 2012 and 2011 were $7.6 million
and $6.8 million, respectively, an increase of $0.8 million from 2011 to
2012. Higher product royalty, contracts and grants revenues were
experienced in 2012.

R&D expense for the first nine months of 2012 was $33.7 million, an
increase of $11.1 million compared to $22.6 million in 2011. Increases
in costs were primarily related to our rindopepimut program, including
the ACT IV and ReACT clinical trials, and related consulting expenses in
2012.

G&A expense was $7.4 million and $6.8 million in the first nine months
of 2012 and 2011, respectively. Higher personnel-related, consulting and
rindopepimut-related commercialization expenses as well as investor
relations expenses related to our R&D Day held earlier this year were
offset in part by lower insurance and professional services costs in
2012 compared to 2011.

As of September 30, 2012, Celldex had approximately 60.8 million shares
outstanding.

About Celldex Therapeutics, Inc.

Celldex Therapeutics is the first antibody-based combination
immunotherapy company. Celldex has a pipeline of drug candidates in
development for the treatment of cancer and other difficult-to-treat
diseases based on its antibody focused Precision Targeted Immunotherapy
(PTI) Platform. The PTI Platform is a complementary portfolio of
monoclonal antibodies, antibody-targeted vaccines and immunomodulators
used in optimal combinations to create novel disease-specific drug
candidates. For more information, please visit www.celldextherapeutics.com.

Safe Harbor Statement Under the Private Securities Litigation Reform
Act of 1995: This release contains "forward-looking statements"
made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including those related to the Company's
strategic focus and the future development and commercialization (by
Celldex and others) of rindopepimut (CDX-110), CDX-011, CDX-1135,
CDX-1401, CDX-1127, CDX-301, Belinostat and other products. Forward-looking
statements reflect management's current knowledge, assumptions, judgment
and expectations regarding future performance or events. Although
management believes that the expectations reflected in such statements
are reasonable, they give no assurance that such expectations will prove
to be correct and you should be aware that actual results could differ
materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our limited cash reserves
and our ability to obtain additional capital on acceptable terms, or at
all, including the additional capital which will be necessary to
complete the clinical trials that we have initiated or plan to initiate;
our ability to adapt APC Targeting TechnologyTM
to develop new, safe and effective vaccines against oncology and
infectious disease indications; our ability to successfully complete
product research and further development of our programs; the
uncertainties inherent in clinical testing; our limited experience in
bringing programs through Phase 3 clinical trials; our ability to manage
research and development efforts for multiple products at varying stages
of development; the timing, cost and uncertainty of obtaining regulatory
approvals; the failure of the market for the Company's programs to
continue to develop; our ability to protect the Company's intellectual
property; the loss of any executive officers or key personnel or
consultants; competition; changes in the regulatory landscape or the
imposition of regulations that affect the Company's products; and other
factors listed under "Risk Factors" in our annual report on Form 10-K.

All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the
date of this release. We have no obligation, and expressly disclaim any
obligation, to update, revise or correct any of the forward-looking
statements, whether as a result of new information, future events or
otherwise.

About us

Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body's immune response.